Legacy Dermatology Pllc

Summary Statement of Deficiencies D6168 TESTING PERSONNEL CFR(s): 493.1487 The laboratory has a sufficient number of individuals who meet the qualification requirements of 493.1489 of this subpart to perform the functions specified in 493. 1495 of this subpart for the volume and complexity of testing performed. This CONDITION is not met as evidenced by: Based on personnel records and interview with the testing personnel, the laboratory failed to employee qualified testing personnel that met the educational requirements for high complexity grossing examination in histopathology testing. (refer to D6171) D6171 TESTING PERSONNEL QUALIFICATIONS CFR(s): 493.1489(b) (b) Meet one of the following requirements: (b)(1) Be a doctor of medicine, doctor of osteopathy, or doctor of podiatric medicine licensed to practice medicine, osteopathy, or podiatry in the State in which the laboratory is located or have earned a doctoral, master's or bachelor's degree in a chemical, physical, biological or clinical laboratory science, or medical technology from an accredited institution; (b)(2)(i) Have earned an associate degree in a laboratory science, or medical laboratory technology from an accredited institution or-- (b)(2)(ii) Have education and training equivalent to that specified in paragraph (b)(2)(i) of this section that includes-- (b)(2)(ii)(A) At least 60 semester hours, or equivalent, from an accredited institution that, at a minimum, include either-- (b)(2)(ii)(A)(1) 24 semester hours of medical laboratory technology courses; or (b)(2)(ii)(A)(2) 24 semester hours of science courses that include-- (b)(2) (ii)(A)(2)(i) Six semester hours of chemistry; (b)(2)(ii)(A)(2)(ii) Six semester hours of biology; and (b)(2)(ii)(A)(2)(iii) Twelve semester hours of chemistry, biology, or medical laboratory technology in any combination; and (b)(2)(ii)(B) Have laboratory training that includes either of the following: (b)(2)(ii)(B)(1) Completion of a clinical Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 2 -- laboratory training program approved or accredited by the ABHES, the CAHEA, or other organization approved by HHS. (This training may be included in the 60 semester hours listed in paragraph (b)(2)(ii)(A) of this section.) (b)(2)(ii)(B)(2) At least 3 months documented laboratory training in each specialty in which the individual performs high complexity testing. (b)(3) Have previously qualified or could have qualified as a technologist under 493.1491 on or before February 28, 1992; (b) (4) On or before April 24, 1995 be a high school graduate or equivalent and have either-- (b)(4)(i) Graduated from a medical laboratory or clinical laboratory training program approved or accredited by ABHES, CAHEA, or other organization approved by HHS; or (b)(4)(ii) Successfully completed an official U.S. military medical laboratory procedures training course of at least 50 weeks duration and have held the military enlisted occupational specialty of Medical Laboratory Specialist (Laboratory Technician); (b)(5)(i) Until September 1, 1997-- (b)(5)(i)(A) Have earned a high school diploma or equivalent; and (b)(5)(i)(B) Have documentation of training appropriate for the testing performed before analyzing patient specimens. Such training must ensure that the individual has-- (b)(5)(i)(B)(1) The skills required for proper specimen collection, including patient preparation, if applicable, labeling, handling, preservation or fixation, processing or preparation, transportation and storage of specimens; (b)(5)(i)(B)(2) The skills required for implementing all standard laboratory procedures; (b)(5)(i)(B)(3) The skills required for performing each test method and for proper instrument use; (b)(5)(i)(B)(4) The skills required for performing preventive maintenance, troubleshooting, and calibration procedures related to each test performed; (b)(5)(i)(B)(5) A working knowledge of reagent stability and storage; (b)(5)(i)(B)(6) The skills required to implement the quality control policies and procedures of the laboratory; (b)(5)(i)(B)(7) An awareness of the factors that influence test results; and (b)(5)(i)(B)(8) The skills required to assess and verify the validity of patient test results through the evaluation of quality control values before reporting patient test results; and (b)(5)(i)(B)(8)(ii) As of September 1, 1997, be qualified under 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals qualified under paragraph (b)(5)(i) of this section who were performing high complexity testing on or before April 24, 1995; (b)(6) For blood gas analysis-- (b)(6) (i) Be qualified under 493.1489(b)(1), (b)(2), (b)(3), (b)(4), or (b)(5); (b)(6)(ii) Have earned a bachelor's degree in respiratory therapy or cardiovascular technology from an accredited institution; or (b)(6)(iii) Have earned an associate degree related to pulmonary function from an accredited institution; or (b)(7) For histopathology, meet the qualifications of 493.1449 (b) or (l) to perform tissue examinations. This STANDARD is not met as evidenced by: Based on an interview with the testing personnel and review of education records, the laboratory failed to employ qualified personnel to perform gross examinations for high complexity histopathology testing since the last survey performed on April 5, 2019. Findings include: 1. Review of education records for one of one testing personnel revealed educational requirements were not met for high complexity grossing examination in histopathology testing. 2. During an interview with the testing personnel on May 5, 2022 at approximately 10:00 am it was confirmed one of one testing personnel did not meet the high complexity educational requirements for grossing histopathology specimens. 3. The laboratory performed approximately 60 tests per year. -- 2 of 2 --

Summary Statement of Deficiencies D5203 SPECIMEN IDENTIFICATION AND INTEGRITY CFR(s): 493.1232 The laboratory must establish and follow written policies and procedures that ensure positive identification and optimum integrity of a patient's specimen from the time of collection or receipt of the specimen through completion of testing and reporting of results. This STANDARD is not met as evidenced by: Based on Mohs test log review, Mohs maps review, frozen section slide review, surgical pathology test reports review, and confirmation by staff, the laboratory reports failed to include the case number of the specimen for 11 of 11 test reports reviewed for Mohs micrographic frozen section specimens reviewed from 04/05/2017 to 03/14/2019. Findings include: 1. Mohs test log and maps identified patients by the date of surgery, case number and patient name and location. 2. Mohs surgical chart report did not include the case number to correlate the slides with the surgical reports. 3. Case slides review included the patient's name, case number, and date. 4. In an interview with the laboratory staff on 04/05/2019 at approximately 11:15 A.M. the laboratory staff confirmed the surgical report did not include the case number as did the log, map and slides. D5473 CONTROL PROCEDURES CFR(s): 493.1256(e)(2)(g) (e) For reagent, media, and supply checks, the laboratory must do the following: (e) (2) Each day of use (unless otherwise specified in this subpart), test staining materials for intended reactivity to ensure predictable staining characteristics. Control materials for both positive and negative reactivity must be included, as appropriate. (g) The laboratory must document all control procedures performed. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 3 -- This STANDARD is not met as evidenced by: Based on stain quality control records review, lack of documentation and confirmation by staff, the laboratory failed to record Hematoxylin and Eosin (H&E) stains met the intended reactivity and predictable staining characteristics for 2 of 11 test days reviewed. The laboratory performed approximately 65 test days per year. Findings include: 1. Stain quality control (QC) records failed to include documentation H&E stain was acceptable for use on 06/29/2018 and 03/14/2019. 2. In an interview conducted on 04/05/2019 at approximately 11:15 A.M., staff confirmed stained QC was not entered in the quality control record for 06/29/2018 and 03/14/2019. D5607 HISTOPATHOLOGY CFR(s): 493.1273(d)(f) (d) Tissue pathology reports must be signed by an individual qualified as specified in paragraph (b) or, as appropriate, paragraph (c) of this section. If a computer report is generated with an electronic signature, it must be authorized by the individual who performed the examination and made the diagnosis. (f) The laboratory must document all control procedures performed, as specified in this section. This STANDARD is not met as evidenced by: Based on Mohs micrographic frozen section surgery maps and reports review, lack of documentation, and confirmation by staff, the laboratory failed to ensure the person qualified to perform histopathology slide diagnosis failed to sign the Mohs maps for 2 of 11 Mohs maps reviewed. The laboratory performed approximately 65 cases per year. Findings include: 1. Mohs maps reviewed for case numbers 2018-013 on 04/26 /2018 and 18-024 on 06/29/2018 failed to include the signature or initials of the qualified testing person. 2. In an interview conducted on 04/05/2019 at approximately 11:20 P.M. the laboratory staff confirmed the maps were not signed by the qualified laboratory director (a board certified dermatologist) and histopathology testing person. D6175 TESTING PERSONNEL RESPONSIBILITIES CFR(s): 493.1495(b)(1) Each individual performing high complexity testing must follow the laboratory's procedures for specimen handling and processing, test analyses, reporting and maintaining records of patient test results. This STANDARD is not met as evidenced by: Based on patient test records review, lack of documentation, and confirmation by staff, the laboratory testing personnel failed to follow the laboratory procedure to record the initial biopsy diagnosis on the Mohs surgical map for 2 of 11 reports reviewed, and failed to record the diagnosis for the specimen reviewed for 1 of 11 Mohs maps reviewed, and failed to record cryostat temperatures for 1 of 11 test days reviewed. The laboratory performed approximately 65 Mohs surgeries reviewed. Findings include: 1. Mohs maps reviewed failed to include the specimen site diagnosis report from the reference lab for the initial biopsy for cases 19-012 and 19- 016. 2. Mohs maps reviewed failed to include the determination that the final surgical stage was clear of tumor or if tumor persists for case number 18-01 and 18-024. 3. Cryostat temperature records failed to include documentation the instrument was checked prior to testing patient frozen sections on 02/01/2019. 4. In an interview -- 2 of 3 -- conducted on 04/05/2019 at approximately 11:20 A.M., staff confirmed the maps were missing the final diagnosis on the map report, the signature of the qualified testing person on 2 maps, and failed to record the cryostat temperature on the record chart. -- 3 of 3 --

Summary Statement of Deficiencies No Tags No deficiency details available. Statement of Deficiencies (X1) Provider/Supplier/CLIA Identification Number (X3) Date Survey Completed Name of Provider or Supplier Street Address, City, State -- 1 of 1 --